AB0893 An Analysis of Fatigue in Patients With Psoriatic Disease Utilizing SF-36 Vitality Scores: Results Through Week 24 in Phase 3 Trials of Guselkumab in Patients With Psoriasis and Psoriatic Arthritis
Authors: J. F. Merola, Y. H. Liu, Y. W. Yang, M. Miller, M. Shawi, D. Chan, S. Khattri, L. Savage, W. H. Boehncke, C. Han
Journal: Annals of the Rheumatic Diseases (2022)

Background Patients with chronic inflammatory diseases can experience significant fatigue, negatively impacting health-related quality-of-life. 1,2 Objectives This post-hoc analysis evaluated baseline fatigue severity among patients with psoriasis and/or psoriatic arthritis (PsA) and the effect of guselkumab treatment on patient-reported fatigue. Methods VOYAGE-2 evaluated guselkumab every 8 weeks (Q8W) versus placebo (W16→guselkumab) and adalimumab in treating moderate-to-severe psoriasis. 3 DISCOVER-1 4 and DISCOVER-2 5 evaluated guselkumab Q4W and Q8W versus placebo in treating active PsA. Fatigue was assessed using 36-item Short Form (SF-36) vitality scale score (includes 4 questions on fatigue/energy level); the US population norm=50±10; 5-10-point decrements are typically observed in conditions known to cause fatigue 2 ; scores ≤35 indicate clinically important fatigue 1 ; increases ≥5 indicate clinically meaningful improvement. 2 Results Across randomized groups at baseline, mean SF-36 vitality scores were 47.7-48.5 in psoriasis and 42.2-44.0 in PsA patients; 11%-15% of psoriasis and 20%-28% of PsA patients had scores &lt;35. In psoriasis patients, mean increases in SF-36 vitality score at W16 were: placebo, 1.1; adalimumab, 3.9 (p&lt;0.001 versus placebo); guselkumab, 5.6 (p&lt;0.001 versus placebo); at W24: placebo→guselkumab, 4.6; adalimumab, 3.9; guselkumab, 5.8 (p=0.0148 versus adalimumab). In PsA patients, mean increases at W24 were: placebo, 2.3-4.0; guselkumab, 5.5-7.5 (p≤0.001 versus placebo). Through the placebo-controlled periods, significantly greater proportions of guselkumab-treated patients achieved clinically meaningful improvement in fatigue versus placebo (W16 psoriasis: guselkumab, 48%; placebo, 32%; p&lt;0.001; W24 PsA: guselkumab, 53%-55%; placebo, 34%-44%; p&lt;0.05). Conclusion At baseline, patients with psoriatic disease experienced clinically important fatigue, more so with PsA (20%-28%) than psoriasis (11%-15%). In guselkumab-treated psoriasis and PsA patients, clinically meaningful improvements in fatigue were achieved at W16 and W24, respectively. References [1]Skoie IM et al. Br J Dermatol. 2017;177:505-12 [2]Bjorner JB et al. Curr Med Res Opin. 2007;23:731-9 [3]Reich K et al. J Am Acad Dermatol . 2017;76:418-31 [4]Deodhar A et al. Lancet . 2020;395:1115-25 [5]Mease PJ et al. Lancet . 2020;395:1126-36 Disclosure of Interests Joseph F. Merola Consultant of: AbbVie, Arena, Biogen, Bristol-Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma, Yi-Hsuan Liu Employee of: Janssen Global Services, LLC and may own stock or stock options in Johnson &amp; Johnson, Ya-Wen Yang Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson &amp; Johnson, and may own stock or stock options in Johnson &amp; Johnson, Megan Miller Employee of: Janssen Research &amp; Development, LLC and may own stock or stock options in Johnson &amp; Johnson, May Shawi Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson &amp; Johnson, and may own stock or stock options in Johnson &amp; Johnson, Daphne Chan Employee of: Janssen Scientific Affairs, LLC and may own stock or stock options in Johnson &amp; Johnson, Saakshi Khattri Speakers bureau: Abbvie, Eli Lilly, UCB, Janssen, Paid instructor for: Abbvie, Eli Lilly, UCB, Janssen, Consultant of: Abbvie, Eli Lilly, UCB, Janssen, Grant/research support from: Pfizer, Abbvie, Leo, BMS, Eli Lilly, Laura Savage Speakers bureau: AbbVie, Almirall, Amgen, Celgene, Celltrion, Eli Lilly, Galderma, Janssen, LEO Pharma, MSD, Novartis, Sanofi and UCB Pharma, Consultant of: AbbVie, Almirall, Amgen, Celgene, Celltrion, Eli Lilly, Galderma, Janssen, LEO Pharma, MSD, Novartis, Sanofi and UCB Pharma, Grant/research support from: Janssen and Pfizer, Wolf-Henning Boehncke Speakers bureau: AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, and UCB Pharma; and has received a research grant from Pfizer, Consultant of: AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, and UCB Pharma; and has received a research grant from Pfizer, Chenglong Han Employee of: Janssen Global Services, LLC and may own stock or stock options in Johnson &amp; Johnson